WO2015034742A1 - Medical device application for configuring a mobile device into an external controller for an implantable medical device - Google Patents
Medical device application for configuring a mobile device into an external controller for an implantable medical device Download PDFInfo
- Publication number
- WO2015034742A1 WO2015034742A1 PCT/US2014/053166 US2014053166W WO2015034742A1 WO 2015034742 A1 WO2015034742 A1 WO 2015034742A1 US 2014053166 W US2014053166 W US 2014053166W WO 2015034742 A1 WO2015034742 A1 WO 2015034742A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- mobile device
- medical device
- mda
- hardware modules
- ipg
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37264—Changing the program; Upgrading firmware
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37235—Aspects of the external programmer
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F9/00—Arrangements for program control, e.g. control units
- G06F9/06—Arrangements for program control, e.g. control units using stored programs, i.e. using an internal store of processing equipment to receive or retain programs
- G06F9/44—Arrangements for executing specific programs
- G06F9/4401—Bootstrapping
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F9/00—Arrangements for program control, e.g. control units
- G06F9/06—Arrangements for program control, e.g. control units using stored programs, i.e. using an internal store of processing equipment to receive or retain programs
- G06F9/44—Arrangements for executing specific programs
- G06F9/4401—Bootstrapping
- G06F9/4406—Loading of operating system
- G06F9/441—Multiboot arrangements, i.e. selecting an operating system to be loaded
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F9/00—Arrangements for program control, e.g. control units
- G06F9/06—Arrangements for program control, e.g. control units using stored programs, i.e. using an internal store of processing equipment to receive or retain programs
- G06F9/44—Arrangements for executing specific programs
- G06F9/4401—Bootstrapping
- G06F9/4411—Configuring for operating with peripheral devices; Loading of device drivers
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16Z—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR
- G16Z99/00—Subject matter not provided for in other main groups of this subclass
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37235—Aspects of the external programmer
- A61N1/37247—User interfaces, e.g. input or presentation means
Definitions
- a SCS system typically includes an Implantable Pulse Generator (IPG) 10, which includes a biocompatible device case 12 formed of titanium, for example.
- the case 12 typically holds the circuitry and battery 14 necessary for the IPG to function.
- the IPG 10 is coupled to electrodes 16 via one or more electrode leads 18 (two of which are shown).
- the electrodes 16 are coupled to the IPG 10 at one or more lead connectors 20 fixed in a header 22, which can comprise an epoxy for example.
- lead connectors 20 fixed in a header 22, which can comprise an epoxy for example.
- there are sixteen electrodes although the number of leads and electrodes is application specific and therefore can vary.
- two electrode leads 18 are typically implanted on the right and left side of the dura within the patient's spinal cord. The proximal ends of the leads 18 are then tunneled through the patient's flesh to a distant location, such as the buttocks, where the IPG case 12 is implanted, at which point they are coupled to the lead connector(s) 20.
- external medical devices such as external controller 50 have been built by the manufacturer of the IPGs, and thus such external devices are generally dedicated to only communicate with such IPGs.
- the inventor has realized that there are many commercial mobile devices, such as mobile cell phones and multi-function tablets, that have the necessary configurable hardware and software to function as an external controller for an IPG or other implantable medical device.
- Using such mobile devices as external controllers for an implantable medical device would benefit both manufacturers and end users: manufacturers would not need to build dedicated external controllers that end users must buy, and end users could control their IPGs without the inconvenience of having to carry additional custom external controllers.
- Mobile devices are often configured with necessary hardware and software to communicate with other devices using short-range protocols, such as Bluetooth, Bluetooth Low Energy (BLE), Near Field Communication (NFC), Zigbee, and WiFi, as well as by using long-range cellular telephony protocols, any of which can be used to ultimately wireless connect the mobile device to the Internet or other network. While such communication channels allow for communication with an implantable medical device, they also render mobile devices less secure than traditional dedicated external controllers, particularly because they are prone to cyber attack, to computer viruses or malware, or to other intentional forms corruption.
- short-range protocols such as Bluetooth, Bluetooth Low Energy (BLE), Near Field Communication (NFC), Zigbee, and WiFi
- Systems and related methods including an implantable medical device (IMD) and a storage device.
- the storage device includes a medical device application (MDA) stored in a non-transitory machine-readable medium configured for execution by a mobile device.
- the MDA is configured when executed (e.g., when selected for execution as an icon on a display of the mobile device) to initialize the mobile device from a first configuration into a second configuration for use as a medical device by performing one or both of:
- the mobile device provides a graphical user interface 197, in which the MDA 200 is displayed as an icon and is selectable by the user in typical fashion. Icons for other downloaded applications 196 that the user can select may also be displayed. Such other applications 196 as well as other software tasks may be running in the mobile device 150 when the MDA 200 is started, and are addressed by the MDA as explained in detail below.
- the MDA 200 configures the hardware modules in the mobile device 150 into a known secure configuration (208). During this step, the MDA 200 disables or reconfigures certain hardware modules that are not necessary to its functions, as further described with respect to Figures 6A-6B.
- Disabling of hardware modules in the mobile device 150 at step 208 can be assisted through the use of a Valid Hardware List 206 provided by the MDA 200, as shown in Figure 4.
- the MDA 200 can compare the identified hardware modules (204) with those on the Valid Hardware List 206, and disable the identified hardware modules that do not match.
- List 206 could alternatively comprise an Invalid Hardware List, and thus will disable identified hardware modules matching those on this list, leaving other hardware modules active by default.
- Such lists can be updated as the MDA 200 is periodically updated via the Internet for example. Rules may also be used to determine which hardware blocks to disable, which rules may depend on monitoring the actual operation of the hardware blocks to gauge their potential to conflict with or corrupt the MDA 200.
- the terminable tasks 224 are terminated (218) by the MDA 200, which can be done with the assistance of the task manager referenced earlier.
- Suspendable tasks 226 will eventually be resumed, and so their state information is stored before these tasks are suspended (222).
- storing the state information will allow the MDA 200 to resume the suspended tasks in the state they existed at the time of suspension.
- the task manager can assist in storing state information and in suspending such tasks.
- Valid tasks 228 (Fig. 7D) may continue to run during operation of the MDA 200.
- the MDA can take other configuration steps (230) to further improve initialization of the mobile device 150 as a medical device.
- the MDA 200 can register itself with the mobile device 150's operating system with a suitable (e.g., highest) priority to reduce the possibility that other tasks will interfere with MDA operation.
- the MDA 200 may also partition and protect the memory space it will use to prevent other tasks from accessing MDA data.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201480060450.8A CN105705197B (en) | 2013-09-06 | 2014-08-28 | Mobile device is configured to the medical device application of the peripheral control unit of implantable medical device |
AU2014315471A AU2014315471B2 (en) | 2013-09-06 | 2014-08-28 | Medical device application for configuring a mobile device into an external controller for an implantable medical device |
JP2016528889A JP2016534821A (en) | 2013-09-06 | 2014-08-28 | Medical device applications that configure mobile devices as external controllers for implantable medical devices |
CA2923451A CA2923451A1 (en) | 2013-09-06 | 2014-08-28 | Medical device application for configuring a mobile device into an external controller for an implantable medical device |
EP14767195.2A EP3041571B1 (en) | 2013-09-06 | 2014-08-28 | Medical device application for configuring a mobile device into an external controller for an implantable medical device |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361874863P | 2013-09-06 | 2013-09-06 | |
US61/874,863 | 2013-09-06 | ||
US14/470,221 | 2014-08-27 | ||
US14/470,221 US9186518B2 (en) | 2013-09-06 | 2014-08-27 | Medical device application for configuring a mobile device into an external controller for an implantable medical device |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2015034742A1 true WO2015034742A1 (en) | 2015-03-12 |
Family
ID=52628863
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2014/053166 WO2015034742A1 (en) | 2013-09-06 | 2014-08-28 | Medical device application for configuring a mobile device into an external controller for an implantable medical device |
Country Status (7)
Country | Link |
---|---|
US (1) | US9186518B2 (en) |
EP (1) | EP3041571B1 (en) |
JP (1) | JP2016534821A (en) |
CN (1) | CN105705197B (en) |
AU (1) | AU2014315471B2 (en) |
CA (1) | CA2923451A1 (en) |
WO (1) | WO2015034742A1 (en) |
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JP2017528212A (en) * | 2014-08-21 | 2017-09-28 | ボストン サイエンティフィック ニューロモデュレイション コーポレイション | Use of a dedicated remote controller as a relay device to communicate with an implantable medical device |
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- 2014-08-28 JP JP2016528889A patent/JP2016534821A/en active Pending
- 2014-08-28 AU AU2014315471A patent/AU2014315471B2/en active Active
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US20150073498A1 (en) | 2015-03-12 |
JP2016534821A (en) | 2016-11-10 |
EP3041571B1 (en) | 2017-09-27 |
AU2014315471A1 (en) | 2016-03-24 |
EP3041571A1 (en) | 2016-07-13 |
CN105705197B (en) | 2018-04-13 |
US9186518B2 (en) | 2015-11-17 |
CA2923451A1 (en) | 2015-03-12 |
AU2014315471B2 (en) | 2016-04-14 |
CN105705197A (en) | 2016-06-22 |
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